Unified Patents v. Ipsen Biopharm Ltd.

This case, IPR2025-01531, Unified Patents v. Ipsen Biopharm Ltd., involves a challenge to the patentability of claims of U.S. Patent No. 11,344,552 at the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office. Unified Patents is a member-based organization focused on deterring unsubstantiated or invalid patent assertions, primarily by non-practicing entities (NPEs), through various activities including filing inter partes reviews (IPRs) and providing prior art research. They aim to improve patent quality and reduce frivolous patent litigation. Ipsen Biopharm Ltd. is a global biopharmaceutical company based in the UK, specializing in innovative therapies across oncology, neuroscience, and rare diseases. They develop and commercialize medicines, and their R&D is focused on biotechnological innovations.

The patent at issue, U.S. Patent No. 11,344,552, titled "Methods for treating metastatic pancreatic cancer using combination therapies comprising liposomal irinotecan and oxaliplatin," describes novel therapies for pancreatic cancer. Specifically, it claims methods of treating pancreatic cancer by administering an antineoplastic therapy comprising liposomal irinotecan, oxaliplatin, and 5-fluorouracil, typically once every two weeks. This combination therapy is relevant to Ipsen's FDA-approved product ONIVYDE® (irinotecan liposome injection), which is used in combination with 5-fluorouracil and leucovorin for metastatic pancreatic adenocarcinoma.

The case is currently pending and has been instituted by the PTAB. IPRs are administrative proceedings before the PTAB that offer an alternative to district court litigation for challenging patent validity. In 2025, the USPTO implemented a new interim process for managing PTAB workload, bifurcating institution decisions into discretionary considerations and merits considerations, with the Director now having significant oversight over institution decisions. The institution decision for IPR2025-01531 specifically noted that a request for discretionary denial by Ipsen Biopharm Ltd. was considered and found not appropriate, partly because the challenged patent was not in force for a significant period (issued in 2022), and there was no parallel litigation between the parties. This highlights the PTAB's recent evolving stance on discretionary denials, where the Acting Director, and later Director Squires, has been increasingly involved in institution decisions. The case is notable for being a challenge by Unified Patents, a prominent entity in the IPR landscape, against a pharmaceutical company, Ipsen, regarding a patent covering a cancer treatment which underpins their FDA-approved drug, ONIVYDE®.

This inter partes review (IPR) concerns U.S. Patent No. 11,344,552, owned by Ipsen Biopharm Ltd., and was initiated by Unified Patents. The patent relates to methods for treating metastatic pancreatic cancer using combination therapies.

Here are the key legal developments for IPR2025-01531:

• Petition Filing (2025-09-12): Unified Patents filed a petition for inter partes review of U.S. Patent No. 11,344,552 with the Patent Trial and Appeal Board (PTAB).
• Institution Decision (2026-03-03): The PTAB instituted the IPR, meaning it found that Unified Patents demonstrated a reasonable likelihood that at least one of the challenged claims of Patent No. 11,344,552 is unpatentable. The case is currently in the post-institution phase.

Present Posture:
The IPR is currently pending and in the instituted phase. As such, a Final Written Decision, which would determine the patentability of the challenged claims, has not yet been issued. Details regarding the Patent Owner Preliminary Response, Patent Owner Response, Petitioner Reply, or any oral arguments are not publicly available in the provided search results at this time. There are no trial events, verdicts, post-trial motions, or appeals to report, as these typically follow a Final Written Decision in an IPR or are elements of a district court litigation, which this IPR is not.

Parallel PTAB Proceedings:
Another IPR, IPR2025-00505, also challenges U.S. Patent No. 11,344,552. In that related proceeding, CSPC Pharmaceutical Group Limited is the petitioner. On July 16, 2025, the Acting Director of the USPTO referred the petition in IPR2025-00505 to the Board for consideration of institution on the merits, having determined that discretionary denial of institution was not appropriate. The Director noted that there was no parallel litigation between the parties and that the patent, issued in 2022, had not been in force for a significant period, thus not establishing strong settled expectations for the patent owner.

Unified Patents, as an organization focused on deterring unsubstantiated patent assertions and improving patent quality through actions like inter partes reviews, typically uses a combination of in-house counsel and external law firms for its IPR proceedings.

While a specific power of attorney filing for IPR2025-01531 listing Unified Patents' counsel is not immediately available, publicly accessible information about Unified Patents' typical legal representation in IPRs and its internal legal team provides insight into the likely attorneys involved.

Based on past IPRs and general information, the counsel representing Unified Patents in IPR proceedings often includes:

• Kelly Hughes (In-house Counsel) - Unified Patents. Kelly Hughes serves as in-house counsel for Unified Patents and has been involved in other IPR proceedings for the organization.
• Jordan M. Rossen (In-house Counsel) - Unified Patents, Washington, D.C. Jordan Rossen is Senior Patent Counsel at Unified Patents and has participated in webinars and IPRs related to PTAB interactions.
• Roshan Mansinghani (In-house Counsel) - Unified Patents, Dallas, TX. Roshan Mansinghani is the Legal Head-NPE at Unified Patents and has been a speaker on topics related to PTAB.
• Jonathan Stroud (Chief IP Counsel) - Unified Patents, Washington, D.C. Jonathan Stroud is the Chief IP Counsel for Unified Patents and is a frequent commentator on PTAB and patent quality issues.

Unified Patents also frequently works with external law firms. For example, in previous IPRs, Unified Patents has been represented by attorneys from firms such as Erise IP, P.A. and Haynes and Boone.

It is important to note that Unified Patents functions independently of its members and does not act as a law firm representing individual members, but rather as an entity focused on broader deterrence goals.

I'll research counsel of record for the Patent Owner (Ipsen Biopharm Ltd.) in this IPR, plus check the parallel CSPC proceeding for cross-reference.

Key finding: the record in IPR2025-01531 conflicts with the case metadata (petitioner appears to be Apotex, not Unified Patents). Let me dig further.

Confirmed a major metadata conflict. Now let me pin down the petitioner-side counsel, the parallel district court case, and the attorneys' backgrounds.

Threshold correction before the counsel list

Two things about the record contradict the case metadata, and they affect how this question should be answered:

1. This is not a patent infringement case. IPR2025-01531 is an inter partes review before the PTAB. There is no complaint, no district court docket, and no "defendant" in the Rule 12 sense — the responding party is the Patent Owner, Ipsen Biopharm Ltd. That is the party whose counsel of record the question is really asking about, and it is answerable.
2. The petitioner of record is Apotex Inc., not Unified Patents. Every primary-source document I found in the proceeding — the Board's joinder decision, Patent Owner's Preliminary Response, Patent Owner's Mandatory Notices, and the PTAB's own correspondence — captions the case "APOTEX INC., Petitioner v. IPSEN BIOPHARM LTD., Patent Owner" (U.S. Patent No. 11,344,552), filed September 12, 2025. The docket aggregators agree (IP Verse lists "Apotex Inc. v. Ipsen Biopharm Ltd. et al., IPR2025-01531," Petitioner Counsel "Molenda, John et al."; DrugPatentWatch lists the '552 IPR petitioner as "Apotex Inc.," filed 2025-09-12). I found no record of Unified Patents appearing in IPR2025-01531 (or in any Ipsen '552 IPR). I am flagging this rather than silently overriding the metadata, but the primary-source PTAB filings are unambiguous, and the earlier "Plaintiff representatives" section of this case file — which lists Unified Patents in-house counsel (Hughes, Rossen, Mansinghani, Stroud) and outside firms Erise IP and Haynes and Boone — appears to rest on the erroneous petitioner premise and should be treated as unreliable for this docket.

There is also a status update that supersedes "Pending – Instituted": after the Director granted institution (Paper 15), the Board granted Apotex's motion for joinder to IPR2025-00505 and terminated IPR2025-01531 under 37 C.F.R. § 42.72, with all future filings to be made in IPR2025-00505 (Decision Granting Petitioner's Motion for Joinder, Paper 16, cited/reproduced in NYIPLA PTAB Committee materials, "Paper 16 Entered: March 12, 2026").

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Counsel of record for the Patent Owner ("defendant") — Ipsen Biopharm Ltd.

Source: Patent Owner's Mandatory Notices filed October 10, 2025 in IPR2025-01531, signed by James M. Glass (PTACTS artifact for petition 1558479). All attorneys are at Quinn Emanuel Urquhart & Sullivan LLP, and the same team signed the Patent Owner correspondence in IPR2025-00505 (Glass email of July 2, 2025: "I am lead counsel for Patent Owner Ipsen Biopharm Ltd. in the above IPR proceeding").

Service in the proceeding runs to a matter-specific alias, ipsen-onivyde-qe@quinnemanuel.com (the docket renders it "quinenmanuel.com" — an OCR artifact in the PTACTS copy; the underlying text confirms Quinn Emanuel). Patent Owner consented to email service.

No in-house counsel for Ipsen is identified in the mandatory notices. One unverified lead: the CSPC petition's certificate-of-service page carries a USPTO customer-number reference "153749 – McNeil PLLC/Ipsen, Ipsen Bioscience, Inc.," which looks like Ipsen's patent-prosecution customer number rather than litigation counsel of record. I would not represent McNeil PLLC as litigation counsel without a docket entry confirming it.

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Petitioner-side counsel (the "plaintiff" side) — for completeness, since the naming conflict matters

Apotex Inc. is represented by Steptoe LLP (successor name for Steptoe & Johnson LLP), 1114 Avenue of the Americas, New York, NY 10036:

Sources for this side: the Board's joinder decision signature block ("FOR PETITIONER APOTEX: John Molenda, Lawrence Kass, Jordan Markham, Michael Green, STEP…"), Apotex/Steptoe powers of attorney in companion Apotex IPRs (e.g., IPR2024-00631, IPR2023-00512) listing Molenda/Kass/Doh/Green, and the PTAB email thread addressing "jmolenda@steptoe.com; lkass@steptoe.com; jmarkham@steptoe.com" as Petitioner's counsel of record (Ipsen's certificate of service, Oct. 10, 2025). I did not see the Paper 1 power of attorney or an updated § 42.8 notice in IPR2025-01531 itself, so the exact role designations (lead vs. backup) on the petitioner side are inferred from the companion filings.

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Cross-check: the operative (joined) proceeding, IPR2025-00505

Because 01531 was terminated into 00505, that is now the live docket. There, Ipsen's Quinn Emanuel team is unchanged, and petitioner-side counsel is Fox Rothschild LLP for CSPC Pharmaceutical Group Limited, CSPC Ouyi Pharmaceutical Co., Ltd., and Conjupro Biotherapeutics, Inc.: lead counsel Luke (Lukas) Toft (Reg. No. 75,311, Minneapolis), backup